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Can a PI3K inhibitor boost presurgery breast cancer treatment?

NCT ID NCT05306041

Disease control Sponsor: GBG Forschungs GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether adding the drug inavolisib to hormone therapy and the antibody combination trastuzumab plus pertuzumab helps shrink HER2-positive, HR-positive breast tumors before surgery. The trial enrolls 170 patients with early-stage breast cancer that has a PIK3CA mutation. Participants receive either the standard presurgery treatment or the same treatment plus inavolisib. The main goal is to see how many patients have no remaining invasive cancer in their breast and lymph nodes at surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inavolisib, a PI3K inhibitor, added to endocrine therapy and the antibody combination trastuzumab plus pertuzumab
What this could lead to
If it works, adding inavolisib could help more women clear their tumors before surgery, which may improve long-term outcomes.
What could go wrong
This is a phase 2 trial with 170 patients, so results may not hold in larger studies. Inavolisib can cause side effects like high blood sugar and rash, and the combination may not be better than standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures. 2. Untreated, unilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration alone is not sufficient. Incisional biopsy is not allowed. 3. Tumor lesion in the breast must be measurable in two dimensions, preferably by sonography. 4. Patients must be in the following stages of disease: • cT1b - cT3 regardless of nodal status In patients with multifocal or multicentric breast cancer the largest lesion (target lesion) should be measured. 5. HR+/HER2+ disease with centrally confirmed ER-status, PR-status, HER2-status, PIK3CA mutation (tumor), Ki-67 value and TILs on core biopsy (target lesion). ER/PgR positive and HER2-positive is defined according to current ASCO/CAP guidelines. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy of target lesion has therefore to be sent to the GBG central pathology laboratory prior to randomization. In patients with multifocal or multicentric breast cancer, all non-target lesions must also be HR+/HER2+, as confirmed by local testing. 6. Age ≥ 18 years, female and male. 7. ECOG Performance status 0-1. 8. Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 3 months prior to randomization. Results for LVEF must be above 55%. 9. Laboratory requirements: Hematology * Absolute neutrophil count (ANC) ≥ 1.5/ nL * Platelets ≥ 100/ nL and * Hemoglobin ≥ 10 g/dL (≥ 6.2 mmol/L) Hepatic function * Total bilirubin \< ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN * AST and ALT ≤ 1.5x ULN and * Alkaline phosphatase ≤ 2.5x ULN Glucose Metabolism: • Glycosylated hemoglobin (HbA1c) \< 6.5% 10. Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential. A woman is considered to be of childbearing potential if she is not hysterectomized or not postmenopausal. Postmenopausal is defined as: * ≥12 continuous months of amenorrhea with no identified cause other than menopause. * Having undergone bilateral oophorectomy. 11. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for least 7 months after the last dose of PH-FDC SC. Examples of non-hormonal contraceptive methods with a failure rate of \< 1% per year include: bilateral tubal ligation; male partner sterilization; intrauterine devices. For men: men must remain abstinent or use a condom with a spermicidal product during the treatment period and for 7 months after the last dose of PH-FDC therapy to avoid exposing the embryo. Men and women must refrain from donating sperm/eggs during this same period. 12. Staging work-up according to country guidelines prior to randomization including: • Bilateral mammography and/or breast MRI in combination with a breast ultrasound. Exception: In men where MRI is medically not indicated breast ultrasound is sufficient. 13. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria 1. Patients with HER2-negative breast cancer and/or HER2-positive, HR-negative breast cancer. 2. Need of immediate neoadjuvant chemotherapy, e.g. inflammatory breast cancer. 3. Patients with definitive clinical or radiologic evidence of Stage IV cancer. 4. Excisional biopsy or lumpectomy and /or axillary lymph node dissection and/or sentinel lymph node biopsy performed prior to study entry (biopsy of clinical involved LN is warranted). 5. Prior chemotherapy or endocrine therapy or radiation therapy prior to study entry with the following exceptions: • If medically indicated, initiation of endocrine therapy up to 28 days prior to randomization and use of established fertility preservation methods in young patients interested in subsequent pregnancies is allowed. 6. Patients with a history of breast cancer are ineligible with the following exceptions: • Patient has been disease-free for more than 5 years and is at low risk for recurrence (at the investigator's discretion). 7. Patients with a history of any treated malignancy are ineligible in case of high risk of recurrence (at the investigator's discretion) and/or ongoing oncological treatment. This also applies to patients who are at high risk that oncological treatment is indicated during study therapy. 8. Patients with BMI\>30 can be included at the investigator's discretion. 9. Known hypersensitivity reaction to one of the compounds or substances, and/or murine proteins, and/or recombinant human hyaluronidase used in this protocol. 10. Patients with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on FPG and HbA1c. 11. Patients who are immunocompromised as the result of HIV or receiving immunosuppressive therapies. 12. Clinically significant and active liver disease, for example, sclerosing cholangitis, active viral hepatitis B or C infection, or autoimmune hepatic disorders. 13. Patients with inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, and active bowel inflammation (e.g., diverticulitis). 14. Patients with any concurrent ocular or intraocular condition, excluding baseline cataracts, that would require medical or surgical intervention during the study period to prevent or treat vision loss. In addition, patients with active uveitis or vitritis, history of uveitis, or active infectious process in the eye. 15. Patients with currently documented pneumonitis/interstitial lung disease. 16. Known or suspected congestive heart failure (\>NYHA I) and / or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP \>160 / 90 mm Hg under treatment with three antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease. 17. Damaged skin at planned site of subcutaneous (SC) injections (thigh). 18. Patients who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their INR. 19. Concurrent treatment with: • Chronic corticosteroids unless initiated \> 6 months prior to study entry and at low dose (10 mg or less methylprednisolone or equivalent). * Sex hormones. Prior treatment must be stopped before randomization (GnRH a is allowed). * Other experimental drugs or any other anti-cancer therapy. 20. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry. 21. Female patients: pregnancy or lactation at the time of randomization. 22. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent. 23. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.

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Conditions

The condition(s) this trial relates to.

HER2 positive breast carcinoma triple-positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2-positive breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    61 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOSS Antonio e Biagio e Cesare Arrigo

    NOT_YET_RECRUITING

    Alessandria, Italy

  • ASST Lecco Ospendale A. Manzoni

    RECRUITING

    Lecco, Italy

  • AULSS9 Scaligera - Ospedale Mater Salutis di Legnago

    RECRUITING

    Legnago, 37045, Italy

  • Center for Gynecologic Oncology

    RECRUITING

    Düsseldorf, 40235, Germany

  • Centrul ONCOMED SRI

    RECRUITING

    Timișoara, Romania

  • DBZ Onkologie

    RECRUITING

    Berlin, 12623, Germany

  • DIAKOVERE Henriettenstift Frauenklinik

    RECRUITING

    Hanover, 30171, Germany

  • Department of Breast-Center Holweide - Kliniken der Stadt Köln

    RECRUITING

    Cologne, 51067, Germany

  • Department of Gynecology and Obstetrics - University of Ulm

    RECRUITING

    Ulm, 89075, Germany

  • Elisabeth Krankenhaus Brustzentrum

    RECRUITING

    Kassel, 34117, Germany

  • Frauenklinik des Universitätsklinikums Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Fundació IRB Lleida Oncología, Unidad de ensayos clínicos

    RECRUITING

    Lleida, Spain

  • Fundación Instituto Valenciano de Oncología (IVO)

    RECRUITING

    Valencia, Spain

  • GRN Klinik Weinheim

    RECRUITING

    Weinheim, 69469, Germany

  • Gemeinschaftspraxis Haematologie Onkologie

    RECRUITING

    Dresden, Germany

  • Helios Universitätsklinikum Wuppertal

    RECRUITING

    Wuppertal, 42283, Germany

  • Hospital Clinic of Barcelona Medical Oncology

    RECRUITING

    Barcelona, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital General Universitario Morales Meseguer

    RECRUITING

    Murcia, Spain

  • Hospital Universitari Vall d´Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Clinico San Cecilio Oncology

    RECRUITING

    Granada, Spain

  • Hospital Universitario Marquès de Valdecilla Servicio de Oncologia Medica

    RECRUITING

    Santander, Spain

  • Hospital Universitario Ramon y Cajal Servicio de Oncología Médica/ Oficina de Ensayos Clínicos

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Son Espases

    RECRUITING

    Palma de Mallorca, Spain

  • Hospital Universitario Virgen der Rocio

    RECRUITING

    Seville, Spain

  • Hospital de Madrid Notre Sanchinarro (CIOCC)

    RECRUITING

    Madrid, Spain

  • Hämatologie-Onkologie im Zentrum MVZ GmbH

    RECRUITING

    Augsburg, 86150, Germany

  • Institut Catalá dÒncologia (ICO)

    RECRUITING

    Barcelona, Spain

  • Instituti Clinici Scientifici Maugeri S.p.A. SB Oncologia Medica

    RECRUITING

    Pavia, Italy

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"

    RECRUITING

    Cluj-Napoca, Romania

  • Institutul Regional de Oncologie Iasi

    RECRUITING

    Iași, Romania

  • Istituto Europeo di Oncologica

    RECRUITING

    Milan, 20141, Italy

  • KEM Kliniken Essen-Mitte

    RECRUITING

    Essen, North Rhine-Westphalia, 45136, Germany

  • Klinik für Gynäkologie und Geburtshilfe Agaplesion Markus Krankenhaus

    RECRUITING

    Frankfurt, 60431, Germany

  • Klinik für Gynäkologie und Geburtshilfe, Brustzentrum/Studiensekretariat

    RECRUITING

    Berlin, Germany

  • Klinikum Chemnitz gGmbH

    NOT_YET_RECRUITING

    Chemnitz, Germany

  • Klinikum Hanau

    RECRUITING

    Hanau, 63450, Germany

  • Klinikum Worms

    RECRUITING

    Worms, 67550, Germany

  • Mammazentrum HH am Krankenhaus Jerusalem

    RECRUITING

    Hamburg, 20357, Germany

  • Media Vita GmbH (MVZ)

    RECRUITING

    Münster, 48145, Germany

  • Narodny onkologicky ustav

    RECRUITING

    Bratislava, Slovakia

  • Narodowy Instytut Onkologii

    NOT_YET_RECRUITING

    Warsaw, Poland

  • National Center for Tumor Diseases - University Hospital Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Onkologische Schwerpunktpraxis Bielefeld

    RECRUITING

    Bielefeld, 33604, Germany

  • Ospedale di Circolo e Fondazione Macchi

    NOT_YET_RECRUITING

    Varese, Italy

  • Praxis für Hämatologie und Onkologie Koblenz and InVo - Institut für Versorgungsforschung in der Onkologie GbR

    RECRUITING

    Koblenz, 56068, Germany

  • Praxisklinik Krebsheilkunde für Frauen

    RECRUITING

    Berlin, 13597, Germany

  • SOC Oncologia S. Maria della Misericordia

    RECRUITING

    Udine, Italy

  • SRH Wald-Klinikum Gera GmbH

    TERMINATED

    Gera, 07548, Germany

  • Spitalul Clinic Filantropia

    RECRUITING

    Bucharest, Romania

  • St. Louise Frauen- und Kinderklinik

    RECRUITING

    Paderborn, Germany

  • Studienzentrale fuer das MVZ Eggenfelden e.K.

    NOT_YET_RECRUITING

    Eggenfelden, Germany

  • Städtisches Klinikum Dessau

    RECRUITING

    Dessau, 06847, Germany

  • University Hospital Carl Gustav Carus

    RECRUITING

    Dresden, 01307, Germany

  • University Hospital Gießen and Marburg, Campus Marburg

    RECRUITING

    Marburg, 35043, Germany

  • University Hospital Mannheim

    RECRUITING

    Mannheim, 68167, Germany

  • University Hospital Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • Università Politecnica delle Marche - Azienda Ospedaliero Universitarià delle Marche

    NOT_YET_RECRUITING

    Ancona, Italy

  • Universitätsklinikum Essen

    NOT_YET_RECRUITING

    Essen, Germany

  • Universitätsklinikum Schleswig-Holstein

    NOT_YET_RECRUITING

    Kiel, Germany

  • Uo Medicina Oncologica Ospedale Di Carpi

    RECRUITING

    Carpi, Italy

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